Convergence 2022 Call for Proposals

 
Thought leaders: inspire the regulatory community!

Share your knowledge with peers in Phoenix at RAPS Convergence 2022 (11-13 September 2022).
 

The 2022 Convergence Planning Committee invites you to submit a session or workshop proposal for RAPS Convergence 2022. Convergence will be in person in 2022. If your proposal is accepted, you will be expected to travel to Phoenix to present in person.

Submission Cycle: 5 January – 4 February 2022 at 11:59 PM EST

RAPS Convergence is the largest and most well-recognized annual gathering of regulatory professionals, scientists, and innovators globally. Convergence brings together representatives from industry, global regulatory bodies, research, academic and clinical organizations directly involved in managing the regulatory process and aligning science, regulation, and business strategy.

Proposal submissions are blinded and peer-reviewed for quality, educational content, logical presentation, and impact on the global healthcare regulatory community.

The RAPS Convergence Planning Committee reserves the right to request modifications, combine proposals and may not accept all suggested speakers. During the submission process, you will be asked to indicate your agreement to be considered for a combined session if the committee identifies proposals that will work well together.

2022 LEARNING FORMATS

  • Panel
  • Debate
  • Case Studies
  • NEW – Hot Topic: Hot topic submissions are designed to be 20 minutes in length.
  • NEW – Campfire Session: Campfire Sessions begin a lot like a traditional presentation, with a speaker (or multiple speakers) presenting an idea at the front of the room. After 15 minutes, the focus shifts from the presenter(s) to the audience. For the remainder of the session, the presenter(s) become facilitators, inviting comments, insights, and questions from those around the room. Campfire sessions allow attendees to drive their learning and share experiences with others, assisting with networking.

2022 TOPICS

  • Accelerating drug development and approval through pilot programs and initiatives
  • Advertising & Promotion and Labeling
  • Biosimilars
  • Clinical Trial Design and Alternative Data Sources (e.g., diversity, real-world data, precision medicine, patient-focused drug development, drug development tools, pediatric trials, 505(b)(2)s, N-1 trials)
  • CMC & Quality
  • Combination Products
  • Expanded Access/Compassionate Use/Right-to-Try
  • Expedited Designations and Pathways
  • Generic Drug Development and Approval (e.g. complex generics, off-patent drugs w/no competition)
  • Harmonization Efforts (e.g. ICH, APEC, LATAM)
  • Vaccines
  • Innovative Technologies and Platforms (e.g. RMAT, ATMPs/cell and gene therapies)
  • Orphan Drugs and Rare Diseases
  • OTCs (e.g. monograph reform, novel switches)
  • Pharmacovigilance, Risk Evaluation and Mitigation Strategies
  • Recent Developments and Impact of the EU Legislative/Policy Environment
  • Recent Developments and Impact of the US Legislative/Policy Environment (e.g. PDUFA, BsUFA)
  • Recent Developments in Other Geographical Regions Beyond EU and US
  • Real-World Evidence to Support Regulatory Decision-Making
  • Career Transitions
  • Crisis Management
  • Incorporating the Patient Perspective into the Regulatory Process
  • Leadership Skills (e.g. emotional intelligence, body language, etc.)
  • Leveraging AI and Other Innovative Tools
  • Negotiation and Communication Skills
  • Preparing for Health Authority Interactions (meetings/scientific advice, advisory committees)
  • Regulatory Policy and Trends
  • Regulatory Strategy/Global Regulatory Planning
  • Other
  • Companion Diagnostics and Personalized Medicine
  • Emerging Standard Developments
  • Advertising & Promotion and Labeling
  • Medical Device Single Audit Program (MDSAP)
  • Performance Evaluation and Clinical Evidence
  • Recent Developments in EU Regulations (MDR and IVDR)
  • Recent Developments in IVDs
  • Recent Developments in LDTs
  • Advertising, Promotion and Labeling
  • Clinical Evaluation
  • Combination Products
  • DeNovo Process
  • Digital Health/Software as a Medical Device/Mobile Apps and e-Labeling/Wearables
  • Emerging Standard Developments
  • Global Supply Chain Compliance (track and trace, UDI, recent changes, etc.)
  • Harmonization/ IMDRF/AHWP
  • Human Factors Studies/Usability Engineering
  • Medical Device Single Audit Program (MDSAP)
  • Modeling and Simulation
  • Pediatric Medical Devices
  • Post-marketing Clinical Follow-Up (PMCF)
  • Preclinical Studies
  • Real-World Evidence to Support Regulatory Decision-Making
  • Recalls
  • Recent Developments in 510(k)
  • Recent Developments in EU Regulations
  • Recent Developments in Other Geographical Regions Beyond EU and US (e.g. Asia Pacific, Latin America, China, Canada, etc.)
  • Recent Developments in US Regulations (e.g. MDUFA)
  • Regulatory Framework to Support Innovation
  • Risk Management
  • Safety/Adverse Event Reporting
 

Broad Interest (Cannabidiol, Health-Related Foods, AI, Cybersecurity, Data Transparency, Inspections & Audits)

Preconference Workshops

Submit a preconference workshop idea for deep-dive intensive learning. Preconference workshops are a unique opportunity to incorporate different learning and instruction tactics to aid attendees in handling the topic of choice. Workshops can be one or two days. Include a detailed class agenda with the preconference proposal submission.

Topics
  • Biopharmaceuticals
  • Drugs
  • In Vitro Diagnostics
  • Medical Devices
  • Other
 

HOW TO SUBMIT

Visit the RAPS Convergence 2022 Proposal Submission Site to submit your proposal application.
View the tutorial video to help you navigate the submission site.

  About the submission process
  • An account is required to submit a proposal. When creating an account, you must provide a valid e-mail address, as RAPS will rely exclusively on email communications related to proposal submission, disposition, and presentation.
  • Submit proposals online only. Submissions by email, fax, or mail will not be accepted.
  • You may save your progress at any point and return to your saved submission until the deadline date, Friday, 4 February 2022, 11:59 pm Eastern Standard Time (EST).
  • Although you may submit multiple proposed sessions, RAPS will not select more than two submissions from an individual to avoid speaker scheduling conflicts.
  • Please allow several days before the proposal submission deadline to resolve questions or problems with the online submission process.
  • Failure to follow online submission procedures may result in the rejection of the proposal.
  • Late and/or incomplete submissions will not be accepted.
  • The RAPS Convergence Planning Committee reserves the right to request modifications, combine proposals and may not accept all suggested speakers.
 

Proposal Template Tool

To assist in planning, download the proposal template to work on your submission offline. When ready to submit, use the above Call for Proposal link to complete and submit your proposal.

Download Template »
 

IMPORTANT DATES

5 January 2022 Proposal submission opens.
4 February 2022 at 11:59 pm, EST Proposal submissions deadline. No extensions will be granted. 
10 – 28 February 2022 Convergence Planning Committee review process.
6 April 2022 Notifications will go out to all who submitted a complete abstract. 
11 – 13 September 2022 RAPS Convergence 2022, Phoenix, AZ
 

OTHER INFORMATION

If your session proposal is accepted:

  • Presenters will receive complimentary registration for the conference.
  • Preconference workshops are available as an add-on purchase option. RAPS does not provide honorarium to cover expenses for presentations.

If your preconference workshop abstract is accepted:

  • Preconference workshop presenters will receive complimentary registration for  main conference.
  • Registration for other Preconference workshops are available as an add-on purchase option.
  • Stipends are available for workshop presenters who do not receive assistance from their employers or other sources to attend Convergence.